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BIOTEK2021-Bioteknologi for verdiskaping

Optimalisering: Pacertool - a patient specific biofeedback guiding tool to improve Cardiac resynchronization therapy

Alternative title: Pacertool- Pasient spesifikk behandlingsverktøy for å forbedre resynkroniseringsbehandling av hjertesvikt.

Awarded: NOK 6.6 mill.

The Pacertool project is supported by the Research Council of Norway and develops a medical console that will help improve the effect of resynchronization treatment for heart failure. Heart failure is one of the most common causes of death in the Western world. Resynchronization therapy is a very effective therapy in heart failure patients with conduction disorders. The project has developed a method of precision medicine in identifying patients who will have adverse effects of treatment and identify those who will have positive effects. We can also optimize the treatment of those who respond well with a similar method. In this way, we can improve the efficacy of treatment to nearly 100% and save society from significant costs associated with non-effective treatment and the cost of follow-up of severe heart failure patients. Patent protection has filed for three methods developed in the project. At the same time, we have developed software that, along with signal converters connected to the patient, can process patient-specific signals and then advise on patient care. The system opens up for more research and exploitation of data with artificial intelligence together with cloud-based data capture solutions. Through an expanded network of partners, the project has come a long way towards commercialization and company establishment in order to enable the technology to be further developed and marketed for the benefit of the patients. The project is now moved forward as a company to manage and exploit the project results from the current project.

Prosjektet har medført opprettelsen av et selskap som skal ta prosjektresultatene videre. Selskapet bygger på forskningsresultater i prosjektet og patenter utviklet i prosjektet. Kunnskap ervervet i prosjektperioden har vært til nytte i prosessen med opprettelse av selskap. Dette selskapet har allerede lyktes med å få finansiering gjennom Eurostars-Eureka programmet, fra Innovasjon Norge og forskningsrådet. Det er nå 4 ansatte i selskapet og man forventer en dobling av antall ansatte i løpet av 1-2 år. Selskapet satser på internasjonale markeder i USA, Europa og Asia, ved å tilby et system for implantasjon av resynkroniseringspacemakere, PaCRTool-systemet.

The project aim is to improve cardiac resynchronization therapy (CRT) from the present efficiency of 50-60% to near 100%. CRT is the most effective therapy applied for heart failure that has been developed over the last 20 years. It consists of an implantable Device (pacemaker) that connects to the heart via lead electrodes. In certain patients it normalizes life expectancy in a population with mortality rates of about 50% over 5 years. We believe that identification of optimal left ventricular lead positioning and validation of such a position is the most important factor that can be corrected during implantation, to avoid therapy failure. We are therefore developing a software/ hardware platform that will be used together with the equipment used for implantation, to collect and analyse biosignals and potentials from the heart in order to facilitate optimal positioning of the lead electrodes on the heart. The software component will visualize a 3D patient specific model of the heart. This heart model will be used to show tissue characteristics in color coded maps overlaid onto the surface of the heart model in real time. These maps will be modified according to each new input given to the model. The software communicates with the hardware module that will get input in the form of bioptentials presented as maps. The software will at the end provide a combined map based on the biofeedback input that will guide the operator to place the lead electrodes. The critical R&D challenge is the measurement of effectiveness of therapy with bioimpedance at each lead electrode position that can be performed. We have research that support these findings, but we need to confirm this in future clinical studies. In this way suggested regions of optimal response that fulfill certain characteristics can be validated before the optimal position is reached. The project results will find its use in the operating room for CRT device implantation in hospitals.

Funding scheme:

BIOTEK2021-Bioteknologi for verdiskaping